Medical device licence · 13629 · Class 3
ANTI-HUMAN GLOBULIN
Yes: licensed in Canada
Licence status Issued (active); first licensed October 28, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 13629
- Licence holder
- Ortho-Clinical Diagnostics, Inc.Athens, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- October 28, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTI-HUMAN GLOBULIN (RABBIT AND MURINE MONOCLONAL) BIOCLONE ANTI-IGG C3D
- ANTI-HUMAN GLOBULIN ANTI-C3B (LOWER CASE), -C3D (LOWER CASE) BIOCLONE
- ANTI-HUMAN GLOBULIN ANTI-C3D (LOWER CASED) (MURINE MONOCLONAL) BIOCLONE
- ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) HEAVY CHAIN SPECIFIC
- ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) HEAVY CHAIN SPECIFIC
- ANTI-HUMAN GLOBULIN(RABBIT & MURINE MONOCLONAL) BIOCLONE (GREEN) ANTI-IGG
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.